C S I

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C

HONDROITIN

S

ULPHATE

I

RON

C

OMPLEX

P

RODUCT

P

ROFILE

SYNTEX S.A.

Luis De Sarro 501 - (B1838DQK) – Luis Guillón – Buenos Aires – Argentina – Tel./Fax: (54 11) 4367-6100 syntex@syntexar.com – www.syntexar.com

Brief Introduction

Complexes existing between Chondroitin Sulphate and Iron (III) belong to a classification of macromolecular organometallic complexes, which is one of the lines of work at Syntex S.A. Possible complexes between Chondroitin

Sulphate and trivalent iron have gave rise to well known hematinic agents, for oral or parenteral administration.

Martindale 34 th

Edition (1425-1, 2005) defines Chondroitin Sulphate - Iron

(III) Complex as iron source in cases of iron deficiency anemia. This bibliography advises the administration of 900 mg a day at the most, equivalent to 90 mg iron a day. This active ingredient is commercialized in

Europe as oral capsules.

(Condrofer ®, 300 mg CS-Fe per capsule).

When chondroitin sulphate – iron (III) complexes are administered parenterally, bibliography makes reference to them as “Chondroitin Sulphate

Iron Colloid” or “CSIC”, according to nomenclature used by JASN (J. Am.

Soc. of Nephrology) (1)

CSIC is a stable preparation of complexed iron colloid with Chondroitin

Sulphate apt for intravenous administration. In Japan and other Asian countries is commercialized under Blutal ® trade mark (Dainippon Pharma,

Tokio, Japan) in ampoules containing 40 mg/ 10 ml (1)

In order to clarify the designation, it must be said that every agent that provides iron intravenously is a colloid consisting of iron-carbohydrate spheroidal nanoparticles (1). This is important whereas colloid, molecular weight affects iron liberation rate and also active principle clearance of the patient ´s plasma after intravenous injection (1).

Syntex S.A. has developed the mentioned complexes in a molecular weight rank, according to their best therapeutic choice.

SYNTEX S.A.

Luis De Sarro 501 - (B1838DQK) – Luis Guillón – Buenos Aires – Argentina – Tel./Fax: (54 11) 4367-6100 syntex@syntexar.com – www.syntexar.com

Use

As it was mentioned, it is a hematinic of highly recognized utility. Intravenous infusion to mitigate iron loss at hemodialysis is a particular use within this category (2) (3).

Its use as contrast agent in magnetic resonance for clinic tests of hepatic reticulo-endothelial system (4) (5) (6) (7) is also well known and it may be extended to veterinary diagnosis.

Production

Syntex S.A. has prepared this substance to bench-top scale (multigram).

Patent Status

Syntex S.A. has developed Iron III - Chondroitin Sulphate complex obtaining methods by adapting procedures pre-existent in bibliography and has not investigated new uses and applications. According to prior art, patenting should not be aspired.

Note

Ideas and data previously mentioned must be understood just as guidelines in applications development and not as a recommendation of use against any patent.

SYNTEX S.A.

Luis De Sarro 501 - (B1838DQK) – Luis Guillón – Buenos Aires – Argentina – Tel./Fax: (54 11) 4367-6100 syntex@syntexar.com – www.syntexar.com

Bibliographic Reference

1. Danielson, B., JASN, 15, 593-98, (2004)

2. Gupta, A., Nephrol. Dial. Transplantation, 15, 1482-84 (2000)

3. Shimamatsu, K., Nephrol. Dial. Transplantation, 13 [4], 1053 (1998)

4. Kato, T., Suto, Y., Matsuo, T., J. Comput. Assist. Tomogr., Vol. 17 [4],

603-8 (1993)

5. Kamba, M., et al, Yonago Acta Médica, 40, 117-123 (1997)

6. Sugihara, S. et al, Br. J. Radiol. 70 (836) 791-97 (1997)

7. Kresse et al, US Pat. 5427767 (27/06/1995)

SYNTEX S.A.

Luis De Sarro 501 - (B1838DQK) – Luis Guillón – Buenos Aires – Argentina – Tel./Fax: (54 11) 4367-6100 syntex@syntexar.com – www.syntexar.com

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